Summary

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar
pill following complete surgical removal of the tumor with or without chemotherapy after
surgery in Stage IB-IIIA NSCLC patients.

Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"

no longer recruiting

Saint-Petersburg, Russian Federation

State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"

time frame:
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (maximum time on follow-up was 64 months).

Overall Survival in Participants With EGFR Mutation - Positive Tumors

time frame:
Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (maximum time on follow-up was 64 months)

Number of Participants With Adverse Events (AEs)

time frame:
From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- Primary tissue from patient's surgery must be epidermal growth factor receptor
(EGFR)-positive by certain tests
- Patients may have up to 4 cycles of chemotherapy after surgery
- Complete removal of the tumor by surgery
- Able to start drug under the following timelines:
- 6 months from the day of surgery for patients who get chemotherapy
- 3 months from the day of surgery for those who do not get chemotherapy
- Confirmed diagnosis of Stage IB-IIIA NSCLC
- Patients must be accessible for follow-up visits
Exclusion Criteria:
- History of prior radiotherapy for NSCLC either before or after surgery
- History of heart disease or uncontrolled heart arrhythmias within the previous year
- History of poorly controlled gastrointestinal (GI) disorders that could affect the
absorption of study drug
- History of other cancer except certain skin or cervical cancers, patients who have
had other cancer are eligible if they have remained disease free for at least 5 years
- Patients who have received chemotherapy for NSCLC before surgery
- Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with
carcinoid tumors are not eligible.

After the initiation of the study, the sponsor became aware of an error in the drug
dispensing module of the interactive voice response such that most patients who were
randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once.
Since the integrity of the data from these patients was seriously compromised, these
patients were considered unevaluable for the protocol-specified analyses. These participants
are referred to as the breached protocol cohort (BPC) and those still on study treatment at
the time of the breach were offered the option of receiving open-label erlotinib for up to 2
years (including posttreatment and long-term follow-up assessments), not receiving
open-label erlotinib but remaining in the study for posttreatment and long-term follow-up
assessment, or withdrawing consent from treatment and further assessments. Participants who
had discontinued study treatment prior to the breach were not offered open-label erlotinib
and remained in long-term follow-up. Data from the BPC participants were analyzed separately
and were not included in the assessments of primary or secondary endpoints in the randomized
cohort and were not considered part of the primary analyses.The sample size for the
randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed
separately.

Related Tags

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presen